Regulatory Affairs Specialist

Summary

This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle—from development and registration to post‑market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.

• Implement company regulatory affairs procedures.
• Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
• Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
• Collaborate with cross‑functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
• Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
• Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
• Support internal and external audits, including FDA inspections and Notified Body assessments.
• Maintain regulatory files and databases, ensuring accurate and up‑to‑date documentation.
• Participate in post‑market surveillance activities, including adverse event reporting and field actions.
• Provide regulatory input during risk assessments and design control processes.

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• 2–5 years of experience in regulatory affairs, preferably in the medical device industry.
• Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
• Experience with regulatory submissions and product registrations in multiple global markets.
• Excellent written and verbal communication skills.
• Strong organizational and project management abilities.

• RAC certification (Regulatory Affairs Certification).
• Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
• Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.